The Clinical Protocol Scientific Review and Monitoring System of the Robert H. Lurie Comprehensive Cancer Center (Cancer Center) is composed of several key committees including the Clinical Protocol Scientific Review and Monitoring Committee (CPSRMC), Data Monitoring Committee (DMC), and the Audit Committee. The CPSRMC is charged with the responsibility of evaluating all new and ongoing clinical research protocols that have not received scientific review by an NCI-approved peer review group, focusing on the scientific review of new and on-going research. NIH requires that DSM activities be distinct from activities of the scientific review committee;therefore, a second committee, the DMC, is responsible for providing data and safety monitoring for local, investigator-initiated protocols. The DMC meets twice a month to review all open intervention studies that fall under its purview and is responsible for: 1) safety reviews of all local, investigator-initiated clinical trials, 2) reviews of PI monitoring reports submitted for each trial, 3) progress reviews of all clinical trials, including on-going review of accrual, 4) reviews of all audit reports generated by the Audit Committee, 5) reviews of all serious adverse events that occur, and 6) reviews of protocol exceptions/deviations. The Audit Committee was developed in 2001, and is responsible for the conduct of the annual auditing program for local, investigator-initiated protocols. This committee performs complete audits including source document verification, regulatory compliance and drug accountability/pharmacy compliance. Annually the committee audits two trials that are randomly selected, from which 10% of enrolled subjects are selected for review. The Cancer Center's Data and Safety Monitoring Plan was originally approved by NCI in August of 2001 and has undergone three revisions since that time.